Actively Recruiting
Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee
Led by Steven E Harte, PhD · Updated on 2025-09-02
200
Participants Needed
1
Research Sites
244 weeks
Total Duration
On this page
Sponsors
S
Steven E Harte, PhD
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial is being done to better understand how daily treatment with Tetrahydrocannabinol (THC), Cannabidiol (CBD), or the combination of CBD plus THC affects knee osteoarthritis pain and other related symptoms. Consented participants will have a screening period and visit (up to 30 days to treatment start). If participants pass the screening phase, they will be randomly assigned to take one of the investigational study drugs. For this study, participants will not know when or if they are taking CBD, THC, THC plus CBD, and when or if taking placebo. Clinical pain will be assessed at multiple times throughout the study, and eligibility will be re-assessed at two weeks into the treatment period. It is possible that subjects will not be able to participate in the study after 14 days of of treatment. The treatment period will take approximately 16 weeks and then a follow-up period for approximately 2 weeks. In addition to treatment, participants will have clinical assessments, blood draws, questionnaires, daily pain diaries, sensory testing, as well as have functional connectivity magnetic resonance imaging (fcMRI).
CONDITIONS
Official Title
Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to read and speak English to provide informed consent and complete questionnaires
- Willingness to participate in a drug treatment trial
- Confirmed diagnosis of knee osteoarthritis by a medical provider
- Chronic moderate to severe knee pain lasting at least 6 months
- No cannabis or CBD use in the past month
- Availability of Fibromyalgia Survey Criteria score for enrollment balance
- Normal or correctable vision to at least 20/40 for reading instructions
- No contraindications to MRI and ability to lie still for 1 to 1.5 hours during MRI
- Willingness to avoid NSAIDs and acetaminophen for 12 hours before neuroimaging and sensory testing
- Willingness to avoid alcohol and nicotine before testing
- Willingness to avoid intense physical activity causing soreness for 48 hours before testing
- Willingness to maintain stable treatment for knee osteoarthritis pain during the trial
- No use or stable daily use of adjunctive pain medications (excluding opioids)
- Willingness to avoid grapefruit juice or products throughout the study
- Females of reproductive potential must use acceptable birth control during treatment; sexually active males and partners must use effective contraception and males may agree not to donate sperm during treatment
You will not qualify if you...
- Currently involved in litigation related to compensation or disability
- Unable to provide written informed consent
- Previous or planned total knee replacement during study
- Severe physical disabilities such as blindness, deafness, or paraplegia
- Medical conditions impairing physical function like malignancy or autoimmune disorders
- Cannabis or CBD use in the past month by self-report or drug screen
- Current opioid use except tramadol
- Current use of certain medications including valproate, clobazam, warfarin, or strong/moderate CYP enzyme inhibitors or inducers
- Allergies to sesame oil or cannabis/cannabinoids
- Medical or psychiatric conditions preventing study participation (e.g., schizophrenia, psychosis, substance abuse)
- Pregnant or nursing
- Liver failure, cirrhosis, active hepatitis, or uncontrolled diabetes
- High blood pressure above 180/120 mmHg
- Resting heart rate below 50 or above 100 bpm
- Elevated liver enzymes or bilirubin beyond specified limits
- Severe cardiovascular diseases
- Severe claustrophobia preventing MRI
- Unable to fit comfortably in MRI
- Diagnosed peripheral neuropathy
- History of epilepsy, seizures, or head injury
- Any condition judged by study team to prevent completing the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
J
Jaye Minghine
CONTACT
S
Steven Harte, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
OTHER
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here